Business Wire

MA-HOLOGIC-INC

17.11.2020 08:02:10 CET | Business Wire | Press release

Share
Hologic Announces CE Mark of the Genius™ Digital Diagnostics System for Cervical Cancer Screening

Hologic, Inc. (Nasdaq: HOLX) announced today that its new Genius™ Digital Diagnostics System is now CE marked in Europe. Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116006076/en/

For more than 30 years, Hologic has developed and brought to market new advances in cervical cancer screening, including the first liquid-based cytology technology, the ThinPrep® Pap Test, and the first FDA-approved mRNA-based HPV test, the Aptima® HPV Assay. Hologic is redefining cervical cancer screening yet again by introducing Genius Digital Diagnostics for laboratories. The system can rapidly analyze all cells on a ThinPrep Pap test slide, narrowing tens of thousands of cells down to a gallery view of the most diagnostically relevant images. This will help provide healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients they serve.

“Application of AI requires digital images that are of exceptional quality,” said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. “Our teams developed a breakthrough imaging technology that converts physical glass cytology slides into digital images with superior clarity. From this digitalization, advanced image analysis and improved standardization are now achievable.”

Genius Digital Diagnostics enables a more seamless and dynamic collaboration across laboratories within a network, connecting pathologists with remote review so each patient can benefit from the collective knowledge of geographically dispersed experts when needed. Digital case review promises to enhance the experience for lab partners by improving workflow and accelerating review time.

“As a part of our development process, we collaborated with cytotechnologists and pathologists to ensure we were developing a new system to meet their needs,” said Michael Quick, vice president, R&D and Innovation at Hologic. “We’re always innovating so we can help our lab partners detect more diseases and save more lives every day.”

Hologic now offers the first CE-marked comprehensive cervical cancer screening portfolio from sample collection to digital diagnosis. Genius Digital Diagnostics consists of a digital imager for image acquisition, an AI algorithm for analyzing images, an image management server for storing images, and a review station for case review. The complete system is scalable, designed to fit the present and future needs of laboratories.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com .

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Genius™ Digital Diagnostics System. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, Genius Digital Diagnostics, ThinPrep, Aptima and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

Link:

ClickThru

Social Media:

https://www.facebook.com/Hologic/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Infobip Supports Thousands of Startups and Scaleups Through Startup Tribe Programme26.3.2026 10:00:00 CET | Press release

In the first five years of the programme, Infobip has provided significant value in products and services to members, helping them build and scale customer communications worldwide Global AI-first cloud communications platform Infobip, which is celebrating its 20th anniversary this year, has supported thousands of startups and scaleups from over 120 countries in the first five years of its Startup Tribe Programme. Infobip launched its Startup Tribe Programme in May 2021 to help mission-driven startups and scaleups to build and manage their customer communications and engagement strategy and grow their business. It does this by providing access up to $60,000 in credits for Infobip’s services and its global network of advisors, investors, and accelerators. In the first five year, Infobip has provided millions in the value of products and services to its programme members. By eliminating the need to build a global communications infrastructure from the ground up, Infobip’s programme enabl

LTM Positioned as a Leader in ISG’s Provider Lens™ Evaluation for Oracle Cloud and Technology Ecosystem 202526.3.2026 09:58:00 CET | Press release

Recognition highlights LTM’s leadership across key quadrants in the United States and Europe LTM, the Business Creativity partner to the world’s largest enterprises, has been recognized as a Leader in multiple quadrants in the ISG Provider Lens™ Oracle Cloud and Technology Ecosystem 2025 reports for both the United States and Europe by Information Services Group (ISG), a leading global technology research and advisory firm. The ISG Provider Lens™ study evaluates leading Oracle ecosystem service providers across critical capability areas, including: Professional Services Managed Services OCI Solutions and Capabilities LTM’s positioning as a Leader across key quadrants in both regions reflects its strong Oracle ecosystem expertise, AI-led transformation approach, and proven track record in delivering large-scale enterprise cloud modernization programs. In its 2025 study, ISG highlights that the Oracle ecosystem is undergoing a fundamental shift toward AI-native architectures, multicloud-

Bureau Veritas Strengthens Global Sustainable Finance Capabilities with Expanded Climate Bonds Approved Verifier Status26.3.2026 08:30:00 CET | Press release

Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), is pleased to announce the expansion of its geographical scope as an Approved Verifier under the Climate Bonds Standard and Certification Scheme. Additional offices in China, Japan, India, and France are now formally listed in the Climate Bonds Verifiers Directory. This expansion builds on Bureau Veritas’ established role since the approval of its Brazilian office in 2020, further enhancing its ability to support issuers with high-quality, independent verification services across key markets. “Our expanded presence as an Approved Verifier under the Climate Bonds Standard reinforces Bureau Veritas’ commitment to advancing credible, high‑integrity sustainable finance”, said Marc Roussel, Executive Vice President, Urbanization and Assurance at Bureau Veritas. “With verifier capabilities available across key markets, we continue to deliver local expertise with global assurance standards; boosting mark

Invivoscribe® Expands IVDR Portfolio with IdentiClone® Dx IGH Assay Certification26.3.2026 06:13:00 CET | Press release

IdentiClone® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). Commercial availability of the IVDR-certified assay is anticipated by early April 2026. The IVDR replaces the former In Vitro Diagnostics Directive (IVDD), introducing significantly more stringent requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. Under IVDR, in vitro diagnostic devices are classified according to risk from Class A (lowest risk) to Class D (highest risk). Class C devices, such as IdentiClone Dx IGH, are considered high-risk tests that play a critical role in disease diagnosis an

Hytera Introduces PNC660 450MHz: New Device Certified for Power and Energy Mission-Critical Networks26.3.2026 06:00:00 CET | Press release

Hytera Communications, a leading global provider of critical communications technologies and solutions, unveiled the PNC660 450MHz MCX Smart Device – an advanced mission-critical terminal for private 450MHz LTE and 5G networks at MWC Barcelona. Combining broadband voice, video, and data services with multi-layer security, the PNC660 450MHz enables reliable communications across wide operational areas while supporting evolving mission-critical broadband needs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260325346069/en/ Hytera PNC660 450MHz MCX Smart Device for mission-critical 450 MHz networks. The device has also been whitelisted by 450connect, validating its compatibility with dedicated 450MHz broadband networks and readiness for commercial deployment for power, energy providers, and other critical infrastructure. Wide-Area Coverage with Dedicated 450MHz Networks The 450MHz spectrum offers excellent propagation and buil

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye